CountryFocus: Healthcare, Regulatory and Reimbursement Landscape – India

GlobalData, the industry analysis specialist, has released its latest report, “CountryFocus: Healthcare, Regulatory and Reimbursement Landscape – India”. The report is an essential source of information and analysis on the healthcare, regulatory and reimbursement landscape in India. It identifies the key trends in the healthcare market and provides insights into the demographic, regulatory, reimbursement landscape and healthcare infrastructure of India. Most importantly, the report provides valuable insights into the trends and segmentation of the pharmaceutical and medical device markets. It is built using data and information sourced from proprietary databases, secondary research, and in-house analysis by GlobalData’s team of industry experts.

The Indian pharmaceutical market was valued at $19.8B in 2010 and increased to $27.6B in 2016 at a Compound Annual Growth Rate (CAGR) of 5.6%. Its value was forecast to be $30.8B in 2018 and expected to reach $38.3B by 2022. The medical devices industry was valued at $18.9B in 2018 and is forecast to increase to $25.4B in 2022. India offers affordable medical services which has resulted in a rise in the country’s medical tourism market. In 2016, 427,014 medical visas were issued by India. This was 4.85% of the total visas issued by India that year. India has also emerged as a hub for R&D activities for international players due to its cost-effective clinical research.

Scope

The report provides information on the healthcare, regulatory, and reimbursement landscape in the India, and includes:

  • An overview of the pharmaceutical and medical device markets, comprising market size, segmentation, and key drivers and barriers
  • Profiles and SWOT analyses of the major players in the pharmaceutical market (Sun Pharma, Biocon, Lupin, Cipla and Zydus Cadila) and profiles and SWOT analyses of the major players in the medical device market (Roche Diagnostics, DePuy Synthes, Abbott and Allengers)
  • Detailed analysis about recent completed deals in the pharmaceutical and medical device market of India
  • Porter’s five forces analysis for pharmaceutical and medical devices market of India
  • An insightful review of the reimbursement and regulatory landscape, of which analysis includes details of the healthcare reimbursement process, the regulatory agencies and the approval processes for new drugs and medical devices
  • Information regarding recent healthcare policies along with healthcare infrastructure and healthcare expenditure
  • An overview of the opportunities for and challenges to growth in the Indian healthcare market

Reasons to buy

This report will enhance your decision-making capability by allowing you to:

  • Develop business strategies by understanding the trends shaping and driving the Indian healthcare market
  • Drive revenues by understanding the key trends, reimbursement and regulatory policies, pharmaceutical market segments, and companies likely to impact the healthcare market in the future
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and analyzing the performance of various competitors
  • Organize your sales and marketing efforts by identifying the market categories and segments that present the most opportunities for consolidation, investment, and strategic partnership
  • Identify, understand, and capitalize on the opportunities and challenges in the Indian healthcare market

Table of Contents

1 Table of Contents

1.1 List of Figures

1.2 List of Tables

2 Executive Summary

2.1 Executive Summary – Overview

2.2 Key ...

1 Table of Contents

1.1 List of Figures

1.2 List of Tables

2 Executive Summary

2.1 Executive Summary – Overview

2.2 Key Highlights

2.3 Key Events: Indian Healthcare Services, 2011–2018

2.4 Key Events: India Pharmaceutical Market

2.5 Key Events: M&A, VF & PE Deals, Global Pharmaceutical Market, 2017–2018

2.6 Key Events: Mergers and Acquisitions

2.7 Country Profile, India, 2017

3 Overview of Pharmaceutical Market

3.1 Pharmaceutical Market – Overview

3.2 Pharmaceutical Market – Exports

3.3 Pharmaceutical Market – Imports

3.5 Pharmaceutical Market – Supply Channels

3.6 Pharmaceutical Market – Market Segments

3.7 Impact of US-China Trade War on Indian Healthcare

3.8 Medical Tourism

3.9 Pharmaceutical Market – Top Five Disease Areas

4 Overview of Medical Devices Market

4.1 Medical Device Market – Overview

4.2 Medical Device Market – Top Five Segments

4.3 Medical Device Market – Market Segments

4.4 Medical Device Market – Major Players

5 Pharmaceutical and Medical Device Market – Drivers and Barriers

5.1 Drivers

5.2 Barriers

6 Deal Analysis

6.1 Deal Analysis: M&A, VF and PE Deals, Pharmaceutical Market, India

6.2 Deal Analysis: M&A, VF and PE Deals, Medical Device Market, India

7 Pharmaceutical and Medical Device Market – Porter’s Five Forces Analysis

7.1 Pharmaceutical Market, India – Porter’s Five Forces Analysis

7.2 Medical Device Market, India – Porter’s Five Forces Analysis

8 Market Access

8.1 Overview of Healthcare System, India

8.2 Reimbursement Process, India

8.2.1 Overview of Insurance Providers, India

8.2.2 Impact of Ayushman Bharat on Indian Healthcare

8.2.3 Healthcare Spending and Health Price Index, India

8.2.4 Pricing Policies, India

8.3 Regulatory Landscape, India

8.3.1 Overview of Regulatory Agency, India

8.3.2 Market Authorization for New Drug Application (NDA), India

8.3.3 Clinical Trial Regulation Process, India

8.3.4 Market Authorization for Medical Devices, India

8.3.5 Market Authorization for Biosimilars, India

8.3.6 Pharmaceutical Export and Import, India

8.3.7 Intellectual Property Rights, India

8.3.8 Intellectual Property Rights, Patent, India

8.3.9 Intellectual Property Rights, Trademarks, India

8.3.10 Pharmaceutical Advertising Regulations, India

8.3.11 Pharmacy Regulations, India

8.3.12 Labeling and Packaging Regulations, India

9 Country Healthcare Landscape

9.1 Healthcare Policy Highlights

9.2 Healthcare Facilities

9.3 Healthcare Parameters

9.4 Environmental Health

9.5 Healthcare Personnel

9.6 Disease Burden

9.7 Healthcare Expenditure

9.7.1 Healthcare Expenditure – Overview

9.7.2 Share of Center and State Public Health Expenditure

9.7.3 Major Components of Healthcare Expenditure

10 Trade Associations

11 Trade Fairs, India

12 Opportunities and Challenges

13 Appendix

13.1 Research Methodology

13.1.1 Coverage

13.1.2 Secondary Research

13.1.3 Forecasts

13.1.4 Expert Panel

13.2 Bibliography

13.3 Contact Us

13.4 Disclaimer

List of Tables

Table 1: Top Five Therapeutic Areas by Annual Turnover ($B), India, 2017

Table 2: Medical Device Market, India, Revenue by Segment ($B) and Share (%), 2017 ...

Table 1: Top Five Therapeutic Areas by Annual Turnover ($B), India, 2017

Table 2: Medical Device Market, India, Revenue by Segment ($B) and Share (%), 2017

Table 3: Ophthalmic Devices Market, India, Revenue ($M) and Market Share (%) of Major Companies, 2015

Table 4: Cardiovascular Devices Market, India, Revenue ($M) and Market Share (%) of Major Companies, 2017

Table 5: IVD Devices Market, India, Revenue ($M) and Market Share (%) of Major Companies, 2017

Table 6: Diagnostic Imaging Market, India, Revenue ($M) and Market Share (%) of Major Companies, 2015

Table 7: Orthopedic Devices Market, India, Revenue ($M) and Market Share (%) of Major Companies, 2017

Table 8: Conditionalities and Installments under PMMVY, India, 2017

Table 9: Insurance Penetration (%), India, 2016–2017

Table 10: Major Public Insurance Schemes, India, 2017

Table 11: Fees for the Approval of New Drugs, 2018, India

Table 12: Legal Provisions for Permission to Import/Manufacture New Drugs, 2018, India

Table 13: Fees for Clinical Trial/Approval of New Drugs, 2018, India

Table 14: Patent Fees, 2018, India

Table 15: Schedule of Trademark Fees, 2018, India

List of Figures

Figure 1: Pharmaceutical Market, India, Revenue ($B), 2010–2018

Figure 2: Medical Device Market, India, Revenue ($B), 2015–2022

Figure 3: Country Profile, India, 2017 ...

Figure 1: Pharmaceutical Market, India, Revenue ($B), 2010–2018

Figure 2: Medical Device Market, India, Revenue ($B), 2015–2022

Figure 3: Country Profile, India, 2017

Figure 4: Pharmaceutical Market, India, Revenue ($B), 2010–2017

Figure 5: Pharmaceutical Market, India, Revenue Forecast ($B), 2018–2022

Figure 6: Pharmaceutical Exports ($B), India, 2010–2017

Figure 7: Top Export Partners, India, 2017

Figure 8: Pharmaceutical Imports ($B), India, 2010–2017

Figure 9: Top Import Partners, India, 2017

Figure 10:Pharmaceutical Value Chain, India, 2016

Figure 11: Biocon Biosimilar Partners, India, 2017–2018

Figure 12: Pharmaceutical Trade Balance ($M), India-China, 2013–2017

Figure 13: Medical Visas (Number), India, 2013–2015

Figure 14: Guidelines for the Promotion of Wellness and Medical Tourism, India, 2016

Figure 15: Top Five Therapeutic Areas by Annual Turnover ($B), India, 2017

Figure 16: Medical Device Market, India, Revenue ($B), 2015–2020

Figure 17: Medical Device Market, India, Revenue Forecast ($B), 2021–2025

Figure 18: Medical Device Market, India, Revenue by Segment ($B), 2017

Figure 19: Ophthalmic Devices Market, India, Revenue ($B), 2015–2022

Figure 20: Ophthalmic Devices Market, India, Market Share of Major Players (%), 2015

Figure 21: Cardiovascular Devices Market, India, Revenue ($B), 2015–2022

Figure 22: Cardiovascular Devices Market, India, Market Share of Major Players (%), 2017

Figure 23: IVD Devices Market, India, Revenue ($bn), 2015–2022

Figure 24: IVD Devices Market, India, Market Share of Major Players (%), 2017

Figure 25: Diagnostic Imaging Market, India, Revenue ($B), 2015–2022

Figure 26: Diagnostic Imaging Market, India, Market Share of Major Players (%), 2015

Figure 27: Orthopedic Devices Market, India, Revenue ($B), 2015–2022

Figure 28: Orthopedic Devices Market, India, Market Share of Major Companies (%), 2017

Figure 29: Diagnostic Market, India, Revenue ($B), 2015–2020

Figure 30: Diagnostic Market, India, Revenue ($B), 2021–2025

Figure 31: Medical Devices Market, India, Revenue ($B) of Major Companies, 2017

Figure 32: Deal Value and Deal Count, Pharmaceutical Market,India, 2017–2018

Figure 33: Deal Value and Deal Count Quarterly, Pharmaceutical Market, India, 2017–2018

Figure 34: Deal Value and Deal Count Sub-types, Pharmaceutical Market, India, 2017–2018

Figure 35: Top Five Therapy Areas by Deal Value, Pharmaceutical Market, India, 2017–2018

Figure 36: Top Five Therapy Areas by Deal Number, Pharmaceutical Market, India, 2017–2018

Figure 37: M&A Deals by Therapy Area, Pharmaceutical Market, India, 2017–2018 (by value and by number)

Figure 38: Venture Financing Deals by Therapy Area, Pharmaceutical Market,India, 2017–2018 (by value and by number)

Figure 39: Medical Device Market Deals, India, 2017–2018 (by deal value, $M)

Figure 40: Medical Device Market Deals, India, 2017–2018 (by deal Count)

Figure 41: Medical Device Market deals share (by deal count), India, 2017–2018

Figure 42: Medical Device Market deals share (by deal value), India, 2017–2018

Figure 43: Top Five Therapy Areas by Deal Value, Medical Device, India, 2017–2018

Figure 44: Top Five Therapy Areas by Deal Number, Medical Device, India, 2017–2018

Figure 45: M&A Deals by Therapy Area, Medical Device, India, 2017–2018 (by value and by number)

Figure 46: Venture Financing Deals by Therapy Area, Medical Device, India, 2017–2018 (by value and by number)

Figure 47:Private Equity Deals by Therapy Area, Medical Device ,India, 2017–2018 (by value and by number)

Figure 48: Key Regulatory Authorities and Responsibilities, India, 2018

Figure 49: Organization of Health System, India, 2018

Figure 50: OOP Expenditure Per Capita (% of health spending), India, 2010–2017

Figure 51: Annual Rate of Change (%), Health Price Index, India, 2010–2017

Figure 52: CDSCO, Organizational Structure, India, 2018

Figure 53: Outline of Evaluation Process by IND Committee/SECs for IND, India

Figure 54: Approval Process for Application Received in Hard Copy with Respect to Medical Devices

Figure 55: Approval Process for Application Received in the Online Sugam Portal with Respect to Medical Devices

Figure 56: Organizational Structure of the Controller General of Patents, Designs and Trade Marks, India, 2018

Figure 57: Patent Approval Process, India, 2018

Figure 58: Trademark Registration Process, India, 2018

Figure 59: Government Hospitals (Number), India, 2010–2018

Figure 60: Diagnostic Equipment (Number), India, 2015–2022

Figure 61: Hospital Beds (per 1,000 population), India, 2010 – 2017

Figure 62: Life Expectancy (years), India, 2010–2017

Figure 63: Immunization Rate (%), India, 2010–2017

Figure 64: Major Causes of Mortality, Deaths (%), India, 2012

Figure 65: Major Causes of Male Mortality, No. of Deaths (‘000), India, 2016

Figure 66: Major Causes of Female Mortality, No. of Deaths (‘000), India, 2016

Figure 67: Disability-Adjusted Life Years by Major Disease (‘000), India, 2016

Figure 68: Physicians (per 1,000 population), India, 2010–2017

Figure 69: Nurses (per 1,000 population), India , 2010–2017

Figure 70: Registered Dental Surgeons, India, 2010–2017

Figure 71: PM2.5 (µg per m3), India, 2010–2017

Figure 72: CO2 Emissions (k tons), India, 2010–2017

Figure 73: Healthcare Expenditure (% of GDP), India, 2009–2018

Figure 74: Public Health Expenditure (Center-State Share %), India, 2010–2017

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